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Copyright © 2019 The Authors. Published by The Journal of Bone and Joint Surgery, Incorporated. DURCHHOLZ ET AL. CORE SET OF RADIOGRAPHIC PARAMETERS FOR SHOULDER ARTHROPLASTY MONITORING. CRITERIA DEFINED BY AN INTERNATIONAL DELPHI CONSENSUS PROCESS http://dx.doi.org/10.2106/JBJS.OA.19.00025 Page 1 The following content was supplied by the authors as supporting material and has not been copy-edited or verified by JBJS. Supplementary Files File 1: SA Radiological Monitoring v1.0 – Methodology details SA Radiological Monitoring v1.0 Core list of radiological parameters for shoulder arthroplasty (SA) monitoring Overview of Delphi survey details and results A modified Delphi technique was implemented after the selection of a consensus panel of experienced surgeons. Experienced shoulder surgeons were invited to participate after nomination by their peers within professional societies. We conducted three successive online surveys using REDCap1. Respondents to either of the first two surveys were considered panel members for this project. The main and senior authors prepared each survey; a steering committee with worldwide representation was formed before the second survey to support the formulation of a proposal for the imaging parameter definitions and specifications. Each committee member focused on various specific imaging parameters and implemented supplementary literature reviews as required to support the development and consensus process. The steering committee approved the final core set of imaging parameters for SA monitoring. First online survey We surveyed participants about the routinely used imaging technique(s) to monitor SA. A list of imaging parameters that may be considered as part of the monitoring protocol was presented and included radiolucency around the implant, loosening/osteolysis, implant migration with regard to the adjoining bone, signs of shoulder instability, bone formation, bone resorption, stress shielding, scapular notching, implant wear and arthritis (Supplementary File 2). For each selected parameter, participants were asked to provide their opinion on the most important features that should be considered essential for the formulation of a definition as well as the time points at which imaging parameters should be systematically monitored. All respondents supported radiographs as the standard routine imaging technique for monitoring asymptomatic SA (Supplementary File 6). Only 10 surgeons (11%) supported the application of an additional computer tomography (CT) scan followed by magnetic resonance imaging (MRI) reported by 3 surgeons. A preliminary list of imaging parameters was agreed on and respondents provided numerous Copyright © 2019 The Authors. Published by The Journal of Bone and Joint Surgery, Incorporated. DURCHHOLZ ET AL. CORE SET OF RADIOGRAPHIC PARAMETERS FOR SHOULDER ARTHROPLASTY MONITORING. CRITERIA DEFINED BY AN INTERNATIONAL DELPHI CONSENSUS PROCESS http://dx.doi.org/10.2106/JBJS.OA.19.00025 Page 2 were to be further considered except “arthritis” with only 44% supporting the inclusion of this parameter. The inclusion of the parameter “stress shielding” achieved 77% agreement, although several participants stated that this term represented a phenomenon and not a measurable entity. We therefore excluded this parameter while considering that it would manifest as a form of 'bone resorption', a term already considered within the defined parameter set. Other suggested parameters included: the integrity of the acromion; integrity of the rotator cuff; implant failure (breakage, dissociation); bone healing (e.g. in case of osteotomy or tubercle migration); and periprosthetic fractures. Rotator cuff status was not considered, since it cannot be reliably documented using standard radiographs other than via proxy parameters such as humeral head migration in asymptomatic patients. Suggested minimum time points for systematic image monitoring within and after the first 5 years were heterogeneous, and included between 1 and 7 time points from 3 months at the earliest to 5 and more years post-surgery. Radiographic monitoring at 3, 6 and 12 months was supported by 53%, 38% and 77% of respondents, respectively; 62% agreed on a 5-year radiographic check. Core set proposal and second online survey The initial responses were reviewed and resulted in a clear agreement among steering committee members that SA monitoring would be performed using radiographs. A second survey was prepared considering 6 groups of radiographic parameters (implant migration, radiolucency around the implant/implant loosening, signs of shoulder instability, bone resorption/bone formation/osteolysis, implant wear and scapular notching) (Supplementary File 3). Two parameters (stress shielding, arthritis) were not supported. All comments, suggested definitions and scientific references from responses to the first survey were shared anonymously with the steering committee members. The first and senior authors prepared a consolidated proposal based on all suggestions. In addition to the 6 parameters mentioned above, the parameters “osteochondral glenoid erosion” in hemiarthroplasty, “fractures around the implant”, “implant breakage/dissociation” and “bone healing” (e.g. in case of osteotomy or tubercle migration) were considered. In this survey, we also asked participants to indicate the level of severity for a radiographic observation to exhibit in order to be potentially symptomatic and therefore, should be considered an unfavorable event. Finally, we proposed a minimum set of radiographic views including a true anteroposterior (AP) view in 0° abduction and in a neutral position (i.e. neutral to the scapula plane), an axillary view in 90° abduction or Y-view (e.g. if axillary view cannot be obtained due to limited abduction capacity) as well as a standardized monitoring schedule with a set of radiographs within the first week and at 3 and 12 months after surgery. Sixty-eight surgeons participated in the second survey. Proposed parameter definitions and their specifications were widely accepted by over 90% of the participants regarding our initial list from the first Copyright © 2019 The Authors. Published by The Journal of Bone and Joint Surgery, Incorporated. DURCHHOLZ ET AL. CORE SET OF RADIOGRAPHIC PARAMETERS FOR SHOULDER ARTHROPLASTY MONITORING. CRITERIA DEFINED BY AN INTERNATIONAL DELPHI CONSENSUS PROCESS http://dx.doi.org/10.2106/JBJS.OA.19.00025 Page 3 survey (Supplementary File 7). Comments were helpful when considering amendments to our proposal; for instance, we changed the recording of implant migration to 3 categories (none / suspicion / definite), changed the grading of radiolucent lines, made “notching” a specific subset of bone resorption in the scapula, and replaced “implant wear” by “wear of the articular surfaces”. Consensus agreement was reached for additional parameters: osteochondral glenoid erosion in hemiarthroplasty (70% agreement), fractures around the implant (humeral or scapula side, 83%), and implant breakage / dissociation (87%). However, bone healing was not supported (56% agreement). Consensus (75% agreement) was also gained regarding our proposed minimum radiographic view set and schedule, but comments suggested that the 3-month time point be extended to 6 months to offer some flexibility without losing relevance. Third online survey Responses from the second survey were reviewed by the main and senior authors and shared with the steering committee; amendments were made and implemented in a revised proposal that was presented to consensus panel members in a third survey (Supplementary File 4 and Supplementary File 8). 1. Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. Copyright © 2019 The Authors. Published by The Journal of Bone and Joint Surgery, Incorporated. DURCHHOLZ ET AL. CORE SET OF RADIOGRAPHIC PARAMETERS FOR SHOULDER ARTHROPLASTY MONITORING. CRITERIA DEFINED BY AN INTERNATIONAL DELPHI CONSENSUS PROCESS http://dx.doi.org/10.2106/JBJS.OA.19.00025 Page 4 File 2: SA Radiological Monitoring v1.0 - Delphi 01 survey screenshots Copyright © 2019 The Authors. Published by The Journal of Bone and Joint Surgery, Incorporated. DURCHHOLZ ET AL. CORE SET OF RADIOGRAPHIC PARAMETERS FOR SHOULDER ARTHROPLASTY MONITORING. CRITERIA DEFINED BY AN INTERNATIONAL DELPHI CONSENSUS PROCESS http://dx.doi.org/10.2106/JBJS.OA.19.00025 Page 5 Copyright © 2019 The Authors. Published by The Journal of Bone and Joint Surgery, Incorporated. DURCHHOLZ ET AL. CORE SET OF RADIOGRAPHIC PARAMETERS FOR SHOULDER ARTHROPLASTY MONITORING. CRITERIA DEFINED BY AN INTERNATIONAL DELPHI CONSENSUS PROCESS http://dx.doi.org/10.2106/JBJS.OA.19.00025 Page 6 Copyright © 2019 The Authors. Published by The Journal of Bone and Joint Surgery, Incorporated. DURCHHOLZ ET AL. CORE SET OF RADIOGRAPHIC PARAMETERS FOR SHOULDER ARTHROPLASTY MONITORING. CRITERIA DEFINED BY AN INTERNATIONAL DELPHI CONSENSUS PROCESS http://dx.doi.org/10.2106/JBJS.OA.19.00025 Page 7 Copyright © 2019 The Authors. Published by The Journal of Bone and Joint Surgery, Incorporated. DURCHHOLZ ET AL. CORE SET OF RADIOGRAPHIC PARAMETERS FOR SHOULDER ARTHROPLASTY MONITORING. CRITERIA DEFINED BY AN INTERNATIONAL DELPHI CONSENSUS PROCESS http://dx.doi.org/10.2106/JBJS.OA.19.00025 Page 8 Copyright © 2019 The Authors. Published by The Journal of Bone and Joint Surgery, Incorporated.